Clinical trials: Mass Balance Study
Tuberculosis, Tuberculosis, Pulmonary
Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment
This study is a Phase 1, single-center, open-label study to investigate the absorption, metabolism, and excretion of BTZ-043 after a single oral administration of 500 mg BTZ-043 containing 3.7 MBq of [14C]BTZ-043 in 4 healthy…
- Conditions
- Tuberculosis, Tuberculosis, Pulmonary, Bacterial Infections Respiratory, Lung Diseases
- Trial name
- NCT04874948
- Testing
- 500mg BTZ-043 containing 3.7 MBq of [14C]BTZ-043
- Where
- Netherlands
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Michael Hoelscher
Healthy Volunteers
TAK-385 Phase I Absorption, Distribution, Metabolism, Excretion and Absolute Bioavailability Study
The purpose of this 2 part study is to look at how TAK-385 is taken up, broken down and removed from the body when given as a radiolabelled oral solution (by mouth) or as an oral tablet (by mouth) followed by a radiolabelled…
- Trial name
- NCT02252354
- Testing
- [14C]-TAK-385 Oral Solution, TAK-385 Tablets, [14C]-TAK-385 Solution for Intravenous Infusion
- Where
- United Kingdom
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy Males
A Study to Evaluate Metabolism, Excretion, and Mass Balance of [14C]Vapendavir
The goal of this clinical trial is to assess how the body processes, breaks down and removes a new test medicine (vapendavir) from the body in healthy male participants.The main question it aims to answer is how the body handles…
- Trial name
- NCT06834295
- Testing
- Vapendavir
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Altesa Biosciences, Inc.
Pulmonary Disease, Chronic Obstructive
A Single Dose Study to Determine the Excretion, Balance and Metabolic Disposition of Radiolabelled GW642444.
The purpose of this study is to characterise the metabolic disposition of radiolabelled GW642444 when administered orally.
- Trial name
- NCT01286831
- Testing
- [14C]GW642444
- Where
- Netherlands
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Volunteers
Copanlisib Mass Balance Study
The study aims to provide understanding of the relative relevance of the different excretion pathways of Copanlisib in humans, as well as to characterize its metabolite profile.
- Trial name
- NCT02119221
- Testing
- Copanlisib (BAY80-6946)
- Where
- Netherlands
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy Volunteers
A Mass Balance Study Following Subcutaneous Administration of [14C]-ITI-1284 to Healthy Male Subjects
ITI-1284-012 is an open-label, single-dose study to assess the mass balance recovery of radioactivity, and to evaluate the pharmacokinetics, safety and tolerability of ITI-1284 after a single subcutaneous dose of [14C]-ITI-1284…
- Trial name
- NCT06786286
- Testing
- [14C]-ITI-1284
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Intra-Cellular Therapies, Inc.
Healthy Male Subjects
Mass Balance and Metabolism Study of 14C-Z-215
The aim of this Phase I study is to determine the absorption, metabolism, and excretion of 14C-Z-215 in healthy male subjects following a single oral administration at a therapeutically relevant dose level (20 mg).
- Trial name
- NCT02618629
- Testing
- 14C-Z-215
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Zeria Pharmaceutical
Healthy Volunteer
Metabolism and Excretion of [14C]CC-90001 in Healthy Male Subjects
This is a clinical pharmacology study to characterize the biotransformation and excretion of [14C]CC-90001 and to evaluate the safety and tolerability of [14C]CC-90001 following a single oral dose of [14C]CC-90001 in healthy male…
- Trial name
- NCT04655898
- Testing
- [14C]CC-90001
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Celgene
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Study on Mass Balance of [14C]HSK39297 in Healthy Chinese Adult Male Subjects
To evaluate the absorption, metabolism and excretion in healthy Chinese male subjects after a single oral dose of [14C]HSK39297
- Trial name
- NCT06852092
- Testing
- Carbon-14 labeled HSK39297
- Where
- China
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Healthy Male Subjects
Mass Balance Study of TS-142 in Healthy Adult Subjects.
To assess the plasma pharmacokinetics, the routes extent of elimination, and the metabolites of TS-142 after single oral dose of [14C] TS-142 in Japanese healthy male subjects.
- Trial name
- NCT04814771
- Testing
- [14C] TS-142
- Where
- Japan
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Taisho Pharmaceutical Co., Ltd.
Healthy Participants
Metabolism, Excretion, and Mass Balance Study of Quemliclustat in Healthy Adult Participants (ARC-24)
The purpose of the study is to investigate the routes of elimination and overall mass balance of 100 mg quemliclustat containing 75 μCi [14C] following a single IV infusion of [14C]-quemliclustat in healthy adult male…
- Trial name
- NCT07364214
- Testing
- Quemliclustat
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Arcus Biosciences, Inc.
Healthy Subjects, Pharmacokinetics of 14C-labeled of LXI-15028
Mass Balance and Biotransformation Study of [14C]LXI-15028 in Humans
To assess absorption, metabolism and excretion of [14C]-LXI-15028 in Chinese healthy male Subjects following a single oral dose of [14C]LXI-15028 suspension.
- Trial name
- NCT05883306
- Testing
- [14C]LXI-15028
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.
Healthy Subjects
A Study to Evaluate the Mass Balance of [14C] SY-5007 in Healthy Adult Male Subjects in China
This is a single-center, open-label, non-randomized, single dose study in healthy male subjects designed to assess mass balance recovery, metabolite profile and metabolite identification of radio-labeled SY-5007 administered…
- Trial name
- NCT06352190
- Testing
- [14C] SY-5007
- Where
- China
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Shouyao Holdings (Beijing) Co. LTD
Healthy Volunteers
Mass Balance and Pharmacokinetics (PK) of [14C]-DC-806 in Healthy Male Participants
The primary objective of this study is to investigate the rate and routes of excretion, including the mass balance, after single oral dose administration of DC-806 containing 3.7 MBq (100 μCi) of [14C]-DC-806 in urine and feces.
- Trial name
- NCT06045000
- Testing
- DC-806, [14C]-DC-806
- Where
- Netherlands
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company
Healthy
Evaluation of Mass Balance and Absolute Bioavailability of GLPG3667
This is a study in healthy male volunteers to assess how a new test medicine is taken up and broken down by the body as well as its safety and tolerability.
- Trial name
- NCT05335447
- Testing
- GLPG3667 capsule, [14C]-GLPG3667 solution for infusion, [14C]-GLPG3667 capsule
- Where
- United Kingdom
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Lakefront Biotherapeutics NV
Healthy
Mass Balance Study of KBP-5074 in Healthy Male Subjects
This is a Phase 1, open-label, nonrandomized, single-dose mass balance and metabolite identification study in healthy male subjects.
- Trial name
- NCT04634812
- Testing
- KBP-5074
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- KBP Biosciences
HIV-associated Lipodystrophy Syndrome
An Study to Investigate the Recovery, Excretion, and Pharmacokinetics of 14C-GSK1265744 Administered as a Single Oral Dose and a Study to Describe the Pharmacokinetics of a Supratherapeutic Dose of GSK1265744 in Healthy Adult Subjects
This will be a two-part study in healthy adults. Part A is a phase 1, non-randomized, open label, single-dose, single-centre mass balance study utilizing a radiolabeled dose to investigate the recovery, excretion, and…
- Trial name
- NCT01848340
- Testing
- GSK1265744B (sodium salt) containing 14C-GSK1265744B, 150 mg GSK1265744B
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Food Effect, Mass Balance
A Study to Evaluate the Food Effect on RNK08954 in Healthy Participants, and the Mass Balance Study of [14C]RNK08954 in Healthy Adult Male Subjects
An Study of Orally Administered RNK08954 in Healthy Adult Subjects to Determine the Effect of Food on the Pharmacokinetics of RNK08954，Mass Balance Study of [14C] RNK08954 in Chinese Healthy Adult Male Subjects
- Trial name
- NCT07334262
- Testing
- RNK08954
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Ranok Therapeutics (Hangzhou) Co., Ltd.
Healthy Subjects (HS)
A Phase 1 Mass Balance Study of [¹⁴C]SSS17 in Healthy Chinese Males
This study aims to evaluate the absorption, metabolism, and excretion of a single oral dose of [¹⁴C]SSS17 in healthy adult Chinese male subjects, elucidating its overall pharmacokinetic profile in humans to provide essential…
- Trial name
- NCT07025915
- Testing
- [14C]SSS17
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
Clinical Trial, Phase I, Pharmacokinetics
Rogaratinib (BAY1163877) Human Mass Balance Study
The objective of this study is to determine the mass balance and routes of excretion of total radioactivity after a single oral 200 mg dose of [14C]rogaratinib given as a solution.
- Trial name
- NCT03484585
- Testing
- Rogaratinib (BAY1163877)
- Where
- Netherlands
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Bayer